A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of the Extended-Release Tramadol Hydrochloride/Acetaminophen Fixed-Dose Combination Tablet for the Treatment of Chronic Low Back Pain

作者：Lee Jae Hyup; Lee Chong Suh^*

来源：Clinical Therapeutics, 2013, 35(11): 1830-1840.

DOI：10.1016/j.clinthera.2013.09.017

• adverse event
• chronic low back pain
• extended-release tramadol HCl/acetaminophen fixed-dose combination
• functional improvement
• pain relief

Background: Chronic low back pain is a common condition that is often difficult to treat. The combination of tramadol hydrochloride and acetaminophen in an extended-release formulation has been shown to provide rapid and long-lasting analgesic effects resulting from the synergistic activity of these 2 active ingredients. %26lt;br%26gt;Objective: The goal of this study was to evaluate the efficacy and safety of extended-release tramadol hydrochloride 75-mg/acetaminophen 650-mg fixed-dose combination tablets (TA-ER) for the treatment of chronic low back pain. %26lt;br%26gt;Methods: This Phase III, double-blind, placebo-controlled, parallel-group study enrolled 245 patients with moderate to severe (%26gt;= 4 cm on a 10-cm visual analog scale) chronic (%26gt;= 3 months%26apos;) low back pain insufficiently controlled by previous NSAIDs or cyclo-oxygenase-2-selective inhibitors and randomly assigned them to receive 4 weeks of either TA-ER or placebo. The primary efficacy end point was the percentage of patients with a pain intensity change rate %26gt;= 30% from baseline to final evaluation. Secondary end points included quality of life (Korean Short Form-36), functionality (Korean Oswestry Disability Index), and adverse events. %26lt;br%26gt;Results: The percentage of patients with a pain intensity change rate %26gt;= 30% was significantly higher (P %26lt; 0.05) in the TA-ER group than in the placebo group for both the full analysis set and the per-protocol population. Pain relief success rate from baseline was significantly higher with TA-ER versus placebo at days 8 and 15 but not at the final visit. Patients in the TA-ER group had significant improvements versus placebo in role-physical, general health, and reported health transition domains of the Korean Short Form-36 and significantly higher functional improvements in the personal care section of the Korean Oswestry Disability Index. Patient assessment of overall pain control as %26quot;very good%26quot; was also significantly higher with TA-ER than with placebo. Adverse events were reported more frequently with TA-ER than with placebo; the most common adverse events reported were nausea, dizziness, constipation, and vomiting. %26lt;br%26gt;Conclusions: TA-ER was significantly more effective than placebo in providing pain relief, functional improvements, and improved quality of life. It exhibited a predictable safety profile in patients with chronic low back pain.

• 出版日期2013-11